Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04999735
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent is obtained before any assessment is performed.
2. Males and females age 16+ years.
3. Genetically confirmed FSHD.
4. Symptomatic as demonstrated by Lamperti score \>0.
5. Fully functioning Android-based smartphone with Android version 5.0 or higher.
6. Able to comply with the study procedures, prohibitions and restrictions (drug use) as specified in the protocol.
Controls inclusion criteria
Controls eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent is obtained before any assessment is performed.
2. Males and females age 16+ years.
3. Unrelated subjects without FSHD.
4. Fully functioning Android-based smartphone with Android version 5.0 or higher.
5. Able to comply with the study procedures, prohibitions and restrictions (drug use) as specified in the protocol.
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.
2. Positive urine β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening in women of childbearing potential.
3. Wearing a pacemaker or other internal medical device (e.g. Vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS)).
4. Current enrollment in an interventional study.
Controls fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Current or previously diagnosed illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study.
2. Positive urine β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening in women of childbearing potential.
3. Wearing a pacemaker or other internal medical device (e.g. Vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS)).
4. Current enrollment in an interventional study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04999735
Study Brief:
Protocol Section:
NCT04999735